Percutaneous heart valve with inflatable support

ABSTRACT

An implantable prosthetic valve for a human heart is disclosed. The prosthetic valve has an inflatable tubular annular support structure and at least one moveable occluder that controls the flow of blood through the support structure. The support structure has a flow control valve configured for coupling to an inflation lumen for inflating the support structure with an inflation media. The flow control valve seals after decoupling from the inflation lumen and prevents the inflation media from escaping.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/502,164, filed Jul. 13, 2009, which is a continuation of U.S. patentapplication Ser. No. 11/112,847, filed Apr. 22, 2005, now U.S. Pat. No7,641,686, which claims priority under 35 U.S.C. § 119(e) to (1) U.S.Provisional Patent Application No. 60/564,708, filed Apr. 23, 2004, (2)U.S. Provisional patent application Ser. No. 60/568,402, filed May 5,2004, (3) U.S. Provisional Patent Application No. 60/572,561, filed May19, 2004, (4) U.S. Provisional Patent Application No. 60/581,664, filedJun. 21, 2004, (5) U.S. Provisional Patent Application No. 60/586,054,tiled Jul. 7, 2004, (6) U.S. Provisional Patent Application No.60/586,110, filed Jul. 7, 2004, (7) U.S. Provisional Patent ApplicationNo. 60/586,005, filed Jul. 7, 2004, (8) U.S. Provisional PatentApplication No. 60/586,002, filed Jul. 7, 2004, (9) U.S. ProvisionalPatent Application No. 60/586,055, filed Jul. 7, 2004, (10) U.S.Provisional Patent Application No. 60/586,006, filed Jul. 7, 2004, (11)U.S. Provisional Patent Application No. 60/588,106, filed Jul. 15, 2004,U.S. Provisional Patent Application No. 60/603,324, filed Aug. 20, 2004,(12) U.S. Provisional Patent Application No. 60/605,204, filed Aug. 27,2004 and (13) U.S. Provisional Patent Application No. 60/610,269 filedSep. 16, 2004, the entire contents of which are hereby expresslyincorporated by reference herein.

BACKGROUND OF THE INVENTION

According to recent estimates, more than 79,000 patients are diagnosedwith aortic and mitral valve disease in U.S. hospitals each year. Morethan 49,000 mitral valve or aortic valve replacement procedures areperformed annually in the U.S., along with a significant number of heartvalve repair procedures.

Although mitral valve repair and replacement can successfully treat manypatients with mitral valvular insufficiency, techniques currently in useare attended by significant morbidity and mortality. Most valve repairand replacement procedures require a thoracotomy, usually in the form ofa median sternotomy, to gain access into the patient's thoracic cavity.A saw or other cutting instrument is used to cut the sternumlongitudinally, allowing the two opposing halves of the anterior orventral portion of the rib cage to be spread apart, A large opening intothe thoracic cavity is thus created, through which the surgical team maydirectly visualize and operate upon the heart and other thoraciccontents. Alternatively, a thoracotomy may be performed on a lateralside of the chest, wherein a large incision is made generally parallelto the ribs, and the ribs are spread apart and/or removed in the regionof the incision to create a large enough opening to facilitate thesurgery.

Surgical intervention within the heart generally requires isolation ofthe heart and coronary blood vessels from the remainder of the arterialsystem, and arrest of cardiac function. Usually, the heart is isolatedfrom the arterial system by introducing an external aortic cross-clampthrough a sternotomy and applying it to the aorta to occlude the aorticlumen between the brachiocephalic artery and the coronary ostia.Cardioplegic fluid is then injected into the coronary arteries, eitherdirectly into the coronary ostia or through a puncture in the ascendingaorta, to arrest cardiac function. The patient is placed onextracorporeal cardiopulmonary bypass to maintain peripheral circulationof oxygenated blood.

A need therefore remains for methods and devices for treating mitralvalvular insufficiency, which are attended by significantly lowermorbidity and mortality rates than are the current techniques, andtherefore would be well suited to treat patients with dilatedcardiomyopathy. Optimally, the procedure can be accomplished through apercutaneous, transluminal approach, using simple, implantable devices.

The circulatory system is a closed loop bed of arterial and venousvessels supplying oxygen and nutrients to the body extremities throughcapillary beds. The driver of the system is the heart providing correctpressures to the circulatory system and regulating flow volumes as thebody demands. Deoxygenated blood enters heart first through the rightatrium and is allowed to the right ventrical through the tricuspidvalve. Once in the right ventrical, the heart delivers this bloodthrough the pulmonary valve and to the lungs for a gaseous exchange ofoxygen. The circulatory pressures carry this blood back to the heart viathe pulmonary veins and into the left atrium. Filling of the leftventricle occurs as the mitral valve opens allowing blood to be drawninto the left ventrical for expulsion through the aortic valve and on tothe body extremities. When the heart fails to continuously producenormal flow and pressures, a disease commonly referred to as heartfailure occurs.

Heart failure simply defined is the inability for the heart to produceoutput sufficient to demand. Mechanical complications of heart failureinclude free-wall rupture, septal-rupture, papillary wall rupture ordysfunction aortic insufficiency and tamponade. Mitral, aortic orpulmonary valve disorders lead to a host of other conditions andcomplications exacerbating heart failure further. Other disordersinclude coronary disease, hypertension, and a diverse group of musclediseases referred to as cardiomyopothies. Because of this syndromeestablishes a number of cycles, heart failure begets more heart failure.

Heart failure as defined by the New York Heart Association in afunctional classification.

Patients with cardiac disease but without resulting limitations ofphysical activity. Ordinary physical activity does not cause unduefatigue, palpitation, dyspnea, or anginal pain.

Patient with cardiac disease resulting in slight limitation of physicalactivity. These patients are comfortable at rest. Ordinary physicalactivity results in fatigue, palpitation, dyspnea, or anginal pain.

Patients with cardiac disease resulting in marked limitation of physicalactivity. These patients are comfortable at rest. Less than ordinaryphysical activity causes fatigue palpitation, dyspnea, or anginal pain.

Patients with cardiac disease resulting in inability to carry on anyphysical activity without discomfort. Symptoms of cardiac insufficiencyor of the anginal syndrome may be present even at rest. Many physicalactivity is undertaken, discomfort is increased.

Congestive heart failure is described as circulatory congestionincluding peripheral edema. The major factor in cardiac pulmonary edemais the pulmonary capillary pressure. There are no native valves betweenthe lungs and the left atrium therefore fluctuations in left atrialpressure are reflected retrograde into the pulmonary vasculature. Theseelevations in pressure do cause pulmonary congestion. When the heart,specifically the mitral valve, is operating normally correct flow andpressures throughout the circulatory system are maintained. As heartfailure begins these pressures and flow rates decrease or increasedepending upon the disease and vascular location.

Placement of valves between the lung and the left atrium will preventretrograde flow and undesired pressure fluctuations to the pulmonaryvasculature. Mechanical valves may be constructed of conventionalmaterials such as stainless steel, nickel-titanium, cobalt-chromium orother metallic based alloys. Other materials used arebiocompatible-based polymers and may include polycarbonate, silicone,pebax, polyethylene, polypropylene or floropolymers such as Teflon.Mechanical valves may be coated or encapsulated with polymers for drugcoating applications or favorable biocompatibility results.

There are many styles of mechanical valves that utilize both polymer andmetallic materials. These include single leaflet, double leaflet, balland cage style, slit-type and emulated polymer tricuspid valves. Thoughmany forms of valves exist, the function of the valve is to control flowthrough a conduit or chamber. Each style will be best suited to theapplication or location in the body it was designed for.

Bioprosthetic heart valves comprise valve leaflets formed of flexiblebiological material. Bioprosthetic valve or components from human donorsare referred to as homografts and xenografts are from non-human animaldonors. These valves as a group are known as tissue valves. This tissuemay include donor valve leaflets or other biological materials such asbovine pericardium. The leaflets are sewn into place and to each otherto create a new valve structure. This structure may be attached to asecond structure such as a stent or cage for implantation to the bodyconduit.

DESCRIPTION OF THE RELATED ART

The concept of placing a percutaneous valve in the pulmonary veins wasfirst disclosed by Block et all in U.S. Pat. No. 5,554,185. A specificwindsock valve for this application was later described by Shaknovich inU.S. Pat. No. 6,572,652.

SUMMARY OF THE INVENTION

There is provided in accordance with one aspect of the presentinvention, a flow controlled device dimensioned for implantation in ahuman pulmonary vein. The device comprises an inflatable supportstructure in at least one movable occluder that controls the flow ofblood into and out of the pulmonary veins. Implantation of the valvebetween the left atrium and the lung within the pulmonary vein reducesthe likelihood and/or the severity of regurgitant flow increasing thepulmonary pressure which may lead to pulmonary edema and congestion.

In accordance with a further aspect of the present invention, a methodof monitoring a patient comprises monitoring blood flow through thepulmonary veins during the implantation of the device of claim 1. Inaccordance with a further aspect of the present invention, there isprovided a method of monitoring blood pressure comprising monitoringblood pressure through the pulmonary veins during the implantation ofthe pulmonary vein valve.

In accordance with a further aspect of the present invention, there isprovided a method of treating a patient comprising rerouting blood flowfrom the pulmonary veins into a prosthetic chamber, and then back into aportion of the heart. The prosthetic chamber may include at least onevalve, and may serve as a manifold for combining the flow of thepulmonary veins into a single return conduit, which may be placed intocommunication with the left ventrical.

Further features and advantages of the present invention will becomeapparent to those of skill in the heart in view of the detaileddescription of preferred embodiments which follows, when consideredtogether with the attached drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevational schematic view of an axially actuateddeployment device in accordance with the present invention.

FIG. 2 is a side elevational schematic view of a rotationally actuateddeployment device in accordance with the present invention.

FIG. 3 is a fragmentary cut-away view of a distal end of a deploymentcatheter having an implantable device therein.

FIG. 4 is a fragmentary view as in FIG. 3, having a different embodimentillustrated therein.

FIG. 5 is a simplified top view of a section through the heart,illustrating a first valve at a first location in a first pulmonaryvein, and a second valve at a second location in a second pulmonaryvein.

FIG. 6 is a schematic representation of a stent supported valve in apulmonary vein.

FIG. 7 is a simplified back view of the heart, illustrating the locationof the left superior pulmonary vein, left interior pulmonary vein, rightsuperior pulmonary vein and right inferior pulmonary vein.

FIG. 8 is a simplified view of the lungs and left atrium, illustratingthe orientation of the pulmonary veins with respect to the lungs.

FIG. 9A is a perspective schematic view of a Starr-Edwards ball and cagevalve.

FIG. 9B is a perspective schematic view of a single leaflet valve.

FIG. 9C is a schematic perspective view of a bi-leaflet valve.

FIG. 9D is a schematic perspective view of a Reed style or duckbillvalve.

FIG. 9E is a schematic perspective view of a poly-leaflet valve.

FIG. 9F is a schematic perspective view of a tri-leaflet valve having aninflatable support structure.

FIG. 9G is a schematic perspective view of a tri-leaflet valve having analternative inflatable support structure.

FIG. 9H is an elevational cross-sectional view through the valve of FIG.9G.

FIG. 10 is a schematic representation of the heart and pulmonary venouscirculation following redirection of the pulmonary venous flow into theleft ventrical.

FIG. 11 is a cross-sectional view of a ball valve that can be used tocontrol inflation of the inflatable support structure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Implantation of valves into the body has been accomplished by a surgicalprocedure or via percutaneous method such as a catheterization ordelivery mechanism utilizing the vasculature pathways. Surgicalimplantation of valves to replace or repair existing valves structuresinclude the four major heart valves (tricuspid, pulmonary, mitral,aortic) and some venous valves in the lower extremities for thetreatment of chronic venous insufficiency. Implantation includes thesewing of a new valve to the existing tissue structure for securement.Access to these sites generally include a thoracotomy or a sternotomyfor the patient and include a great deal of recovery time. An open-heartprocedure can include placing the patient on heart bypass to continueblood flow to vital organs such as the brain during the surgery. Thebypass pump will continue to oxygenate and pump blood to the body'sextremities while the heart is stopped and the valve is replaced. Thevalve may replace in whole or repair detects in the patient's currentnative valve. The device may be implanted in a conduit or otherstructure such as the heart proper or supporting tissue surrounding theheart. Vessels entering or departing the heart have an attachment orconnection interface where the two components join in transition. Thistransition may provide a secure tissue zone to attach a valve body to.Attachments methods may include suturing, hooks or barbs, interferencemechanical methods or an adhesion median between the implant and tissue.Access to the implantation site may require opening the wall of theheart to access the vessel or heart tissue for attachment. It is alsopossible to implant the device directly into the vessel by slitting inthe longitudinal direction or cutting circumferentially the vessel andsuturing the vessel closed after insertion. This would provide a lessinvasive method to implant the device surgically.

Other methods include a catheterization of the body to access theimplantation site. Access may be achieved under fluoroscopyvisualization and via catheterization of the internal jugular or femoralvein continuing through the vena cava to the right atrium and utilizinga transeptal puncture enter the left atrium. Once into the left atriumconventional and new catheterization tools will help gain access to thepulmonary veins. Engagement of each of the pulmonary veins may require aunique guiding catheter to direct device or catheter placement.Monitoring of hemodynamic changes will be crucial before, during andafter placement of the device. Pressure and flow measurements may berecorded in the pulmonary veins and left atrium. Right atrial pressuresmay be monitored separately but are equally important. Separatecatheters to measure these values may be required.

Valve delivery may be achieved by a pushable deployment of a selfexpanding or shaped memory material device, balloon expansion of aplastically deformable material, rotational actuation of a mechanicalscrew, pulling or pushing force to retract or expose the device to thedeployment site. To aid in positioning the device, radiopaque markersmay be placed on the catheter or device to indicate relative position toknown landmarks. After deployment of the devices the hemodynamicmonitoring will allow the interventional cardiologist to confirm thefunction of the valves. It is possible to place and remove each valveindependently as valves may not be required in all pulmonary veins.

Entry to the body with a catheter may include the internal jugular orfemoral vein. This will allow the user to enter the right atrium eithersuperior or inferiorly and complete a transeptal puncture for accessinto the left atrium. Another approach would be to enter the femoral,brachial or radial artery where the user could access the aortic valveentering the left ventrical, Advancing the device through the leftventrical and past the mitral valve the left atrium can be entered.Utilizing normal cath-lab tools such as guidewires and guide cathetersthe delivery system or catheter can be advanced to the deployment site.Guidewires may measure 0.010-0.035 inches in diameter and 120-350centimeters in length. Slippery coatings may aid in the navigation tothe implantation site due to the vast number of turns and thetortuerosity of the vasculature. A guide catheter may be used to providea coaxial support system to advance the delivery catheter through. Thisguiding catheter may be about 60-180 cm in length and have an outerdiameter of 0.040-0.250 inches. It would have a proximal and distal endwith a connection hub at the proximal end and may have a radiopaque softtip at the distal end. It may have a single or multilumen with a wallthickness of 0.005-0.050 inches and may include stiffening members orbraid materials made from stainless steel, nickel-titanium or apolymeric strand. The catheter material may include extruded tubing withmultiple durometer zones for transitions in stiffness and support. Theinner diameter may have a Teflon lining for enhanced coaxial cathetermovement by reducing the friction coefficient between the two materials.

As illustrated in FIG. 1, the delivery catheter 10 would be constructedby normal means in the industry utilizing extruded tubing, braiding forstiffening means and rotational torqueability. The delivery catheter 10has a proximal end 12 and distal end 14 where the proximal end 12 mayhave a connection hub to mate other cath-lab tools to. The distal end 14may have a radiopaque marker to locate under fluoroscopy. The outerdiameter would measure about 0.030-0.200 inches and have a wallthickness from about 0.005-0.060 inches. The overall length would rangefrom about 80-320 centimeters and have a connection hub or hubs at theproximal end 12 to allow wires, devices and fluid to pass. Theconnection hub would be compatible with normal cath-lab components andutilize a threaded end and a taper fit to maintain seal integrity. Theinner diameter of the catheter 10 would allow for coaxial use to passitems such as guidewires, devices, contrast and other catheters. Aninner lining material such as Teflon may be used to reduce friction andimprove performance in tortuous curves. In addition a braided shaft ofstainless steel or Nitinol imbedded into the catheter shaft 16 mayimprove the torqueability and aid in maintaining roundness of thecatheter lumen.

Multidurometer materials would help soften the transition zones and addcorrect stiffness for pushability in the body. These zones may beachieved through an extrusion process know as bump tubing. Where thematerial inner and outer diameter change during the extrusion process.The entire catheter shaft, can be produced in one piece. Another methodfor producing such a catheter shaft is to bond separate pieces of tubingtogether by melting the two components together and forming a singletube with multiple diameters and or stiffness. The application of heatcan be applied by laser or heated air that flows over the shaft materialor other methods of heat application sufficient to flow the materialstogether.

The shaft material may also consist of stiffening members for transitionzones or bump extrusions to reduced diameter and maintain correctpushability. Lumen characteristics may include single or multi portalsfor guidewire or device entry. Conventional guidewire passage throughthe catheter such as “over-the-wire” may be used or technology such as“rapid-exchange” may aid in procedure ease and catheter exchanges. Sincemultiple devices may be placed in a single catheterization,rapid-exchange may be preferred but not essential. Other features thatmay aid in ease of use include a slippery coating on the outer and orinner diameter such as MDX (silicone) or a hydrophilic layer to alloweasy access to tortuous anatomy. It may be necessary to utilize aballoon to radially expand the device to its final diameter and locationso an inflation lumen and balloon placed distal to the hub could beused. This balloon could be used to pre-dilate the vessel or ostiumwhere the valve may be implanted, Finally elements to transmit signalsexternally could be imbedded into the catheter for pressure and flowreadings or Doppler information. These may include electrical wires,pressure portal or lumens optical fibers.

As illustrated in FIGS. 1-4, delivery of the device 18 viacatheterization of the implantation site will include a mechanism todeploy or expel the device 18 into the vessel or atrium. This mechanismmay include push or pull members 20 and 21 to transmit forces to thedistal portion of the catheter 10. These forces may be appliedexternally to the body and utilize a handle 22 at the proximal end 12 ofthe catheter. Means to transmit forces to the distal end 14 may alsoinclude a rotational member 24 to loosen or tighten, convert a torque 26into a translational force such as a threaded screw 28 and nut or to addor subtract stiffness to the catheter 10 or device 18. The handle 22mechanism may also include a port for hydraulic pressures to betransmitted to the distal portion of the catheter 10 or have the abilityto generate hydraulic forces directly with the handle 22. These forcesmay include a pushing or pulling transmitted to the device 18 orcatheter 10, an exposure of the device 18 to allow for implantation orto expel the device 18 from the catheter. Further forces may include aradial or longitudinal expansion of the device 18 or catheter 10 toimplant or size the location of implantation. The handle 22 may alsoinclude connections to electrical signals to monitor information such aspressures, flow rates, temperature and Doppler information. Anotherimportant use of the handle 22 and catheter 10 is the deploymentmechanism for the device 18. As the device 18 is navigated to the site,attachment between the device 18 and catheter 10 is essential. Manydetachment methods have been used to deploy devices 18 such as stentsand embolic coils through balloon expansion and simple pushable coilsexpelled from the distal end 14 of a catheter 10. The valve device canutilize many different methods to implant at the selected site such asan expulsion out the end of the catheter 10, a mechanical releasemechanism such as a pin joint, unscrewing the device 18 from thecatheter delivery system, a tethered link such as a thread or wire, afusible link as used in a GDC coil deployment, a cutting tool to sever aattachment of the device 18 from the catheter 10, a threaded knot totether the catheter 10 to the device 18 where the as the knot could beuntied or cut, a hydraulic mechanism to deploy, expand or fracture alink between the catheter 10 and the device 18. All above mentionedconcepts may be enhanced be the utilization of a flexible tip to allowacute articulation of the device 18 and delivery catheter 10 to gainaccess to the implantation site.

After the device has been temporarily deployed or positioned, it may beadvantageous to recapture or reposition the device for optimal results.This may include a rotational or translation of the implant of acomplete removal and exchange for a different diameter, length or styledevice. Capture of an implanted device may require a second catheter toreengage the device to remove or reposition to a proper location.

Valve

As illustrated in FIGS. 5-8, in the preferred embodiment the device,such as a valve 30, would be located between the right lung 31 a and/orleft lung 31 b and the left atrium 32 in the right superior pulmonaryvein 34 a, the right inferior pulmonary vein 34 b, the left superiorpulmonary vein 34 c, the left inferior pulmonary vein 34 d and/or in thewall of the left atrium 32. Preferably the valve 30 described above islocated to affect the flow and pressure of blood between the pulmonaryveins 34 a-d and the left atrium 32 or a portion of the left atrium 32and to lessen the symptoms of mitral regurgitation from a dysfunctionalmitral valve 36 including elevations and fluctuations in the pulmonarycirculation. The device 30 may be viewed as a one-way valve limiting orrestricting retrograde flow into the pulmonary circulation, Having asubstantial fatigue life to withstand cyclical operation for a givenperiod of implantation duration will be a factor in selection of bothmaterials and construction. This may include heat treatments to certainportions or all components of the device 30 and analysis of constructionand manufacturing techniques to optimize device 30 life. Additionally acoating may be required to maintain patency of the device 30 duringnormal operation. This may be a surface modification or treatment, acoating added to the device 30 such as heparin or and albumin layer.

The valve could be a valve of any design including bioprosthetic,mechanical or tissue valves. Examples of commonly used prosthetic valvesinclude a ball valve 40 illustrated in FIG. 9A such as a Starr-Edwards,a single leaflet valve 50 illustrated in FIG. 9B such as a Bjork-Shileyvalve, a bileaflet or hi-disk valve 60 illustrated in FIG. 9C or anartificial tricuspid valve such as a Magna or Cribier, a reed stylevalve 70 illustrated in FIG. 9D, a slit in a membrane of material, aduckbill style or many other styles unmentioned here but apparent to oneskilled in the art. To facilitate delivery of the valve and to improvehemodynamics other mechanical valve designs may be utilized, includingthe poly-leaflet valve and flexible leaflet valves as described below.The valves may be deformable to allow for percutaneous delivery or rigidto enable structural integrity. They may include one of the belowmentioned features or a combination of a plurality thereof to addperformance and or reduce size.

Mechanical

As illustrated in FIG. 9A, the early valve implants began in the early1960's with ball valves 40 such as the Starr-Edwards. This valve 40includes a base 42 and mechanical structure 44 where a ball 46 iscaptured and allowed to travel longitudinally sealing flow in onedirection and allowing flow in the other. The movement of the ball 46 isdriven by flow.

As illustrated in FIG. 9B, disk style valves 50, known as Bjork-Shiley,entered the market in the 1970's and began with a single disk 52supported in a ring 54 where the disk 52 was allowed to pivot within thering 54 allowing flow in one direction and sealing flow in the other.The tilt angle ranged from about 60-80 degrees.

As illustrated in FIG. 9C, bi-disk valves 60 include two tilting disksto allow for greater flow and less turbulence. These valves 60 wereintroduced in the 1980's and seem to be the standard choice.

As illustrated in FIG. 9E, also disclosed is a poly-leaflet valve 80 forimplantation in the body. The valve 80 would contain four or moreleaflets 82 free to pivot near the annulus 84 of the valve 80.Increasing the number of leaflets 82 allows the valve 80 to collapse toa smaller diameter, for percutaneous or minimally invasive delivery,while also providing good hemodynamics, and allowing the leaflets 82 tobe made from a rigid material ideally one that has clinically provengood biocompatibility in valve applications.

Also disclosed is a flexible leaflet valve for implantation in the body.A mechanical prosthetic valve manufactured from a flexible material suchas a polymer or tissue material that allows the leaflets to besubstantially deformed during delivery if the valve. The leaflets couldalso consist of metal or a polymeric coated sub straight. If metallicthe leaflet material could be a super elastic alloy such as Nitinol oran alloy with a relatively high yield stress and relatively low modulusof elasticity such as certain titanium alloys. Someone skilled in theart will understand the relationship between elastic modulus and yieldstress; in order to select materials with a maximum amount of strainavailable before yielding begins. This would allow for recoverabledeformation during delivery and may enhance fatigue characteristics.

A valve that functions as an iris could also be utilized as a prostheticvalve. The iris could be opened and closed by an internal or externalforce, a differential in pressure or by the flow of blood.

Tissue

There are several types of tissue valves that have been previouslyimplanted as replacement valves in the human coronary system. Theseinclude valves from human cadavers, and valves from other mammals suchas pigs horses and cows utilizing sometimes pericardial tissue to builda valve by sewing techniques. Any of these types of valves could beimplanted as described both in a surgical procedure or acatheterization. Additionally other valves such as from the largervenous vessels from smaller animals could be utilized because of thesmaller size and reduced flow requirements of the pulmonary veins.

A valve from the patient may also be used, by transplanting the valveinto a pulmonary vein. Many native valves could be used such as a venousvalve from the lower extremities. The preferred embodiment is to use anative valve from a large peripheral vein.

Orifice

The flow control device could be an orifice of fixed or adjustablediameter that limits the amount of blood that flows through thepulmonary veins. The orifice diameter could be adjusted remotely or bysome hemodynamic mechanism such as pressure or flow differential orpressure change.

Flap

The flow control device could consist of one or more flaps locatedwithin the atrium to prevent the back flow of blood into the pulmonaryveins. The flow control device could be a pivoting or flexible flap thatmoves to block the ostium of one or more pulmonary veins or it could bea rigid or semi rigid flap or flaps that control the bloods flow pathreducing or eliminating the backwards flow of blood in to the pulmonaryveins.

Flow Controlled

In the preferred embodiment the flow through the valve is flowcontrolled, To the extent possible flow is allowed only in a firstdirection and not in a second direction. The first direction is intendedto be away from the lungs and towards the heart.

Pressure Controlled

The valve may function such that it is pressure controlled that is itopens at a preset pressure differential. The pressure control could beimplemented in several ways. The one-way valve could allow flow in thebackward or restricted direction at a certain pressure differential.This may be advantageous in preventing the overloading of the atrium,Alternatively the valve could be designed to open in its normal flowdirection at a preset pressure differential.

Metallic

The valve or flow control device may be manufactured partially orcompletely from metallic components. Depending on the mechanicalproperties required various biocompatible metals might be chosen. Theseinclude, but are not limited to various stainless steel alloys,cobalt-chrome-nickel-alloys, super-elastic alloys such as Nitinol,Tantalum and titanium and its alloys. The device could be self-expandingin nature if desired.

Polymer

The valve or flow control device may be manufactured partially orcompletely from polymeric components. Various biocompatible polymers maybe used depending on the desired mechanical properties. Some examples ofbiocompatible polymers include silicone, polyethylene and,flouropolymers such as Teflon.

External Cuff

All or part of the flow control device may attach to the outside of thepulmonary vein by applying external force to the vein the device affectsthe flow through the vein, Both compressive or expansive forces could beapplied to change the vessel geometry. An external portion of the devicelocated around the vein may also help to secure a second portion of thedevice within the vein.

Electrical

Valves may be actuated to synchronize with the proper opening andclosing times through an internal or external device such as apacemaker. There may require an actuation device to drive the motion ofthe valve open and dosed. Pressure gradients could be used to sense whenactuation is necessary.

Vane

The flow control device may include a vane that introduces a swirlingmotion to the blood. The vane may be used to improve hemodynamic flowthrough another portion of the flow control device or it may be usedalone to improve the hemodynamics of the native anatomy. The vane mayadditionally function or rotate in a single direction only to limitflow.

Pump

In one embodiment the flow control device located between a portion ofthe pulmonary veins and the heart consists of a pump. The pump may bepowered externally, internally or by the biological movement of theheart. The pump may be located inside the pulmonary vein inside theatrium outside the heart or, outside the body.

Inflatable Support Structure

As illustrated in FIGS. 9F, 9G, 9H and 11, certain pulmonary vein valvesin accordance with the present invention include an inflatable supportstructure 90, as is disclosed, for example, in the context of an atrialvalve, in the provisional applications incorporated by reference above.

As illustrated in FIGS. 9F and 11, the inflatable support structure 90comprises at least one annular ring 92, such as an annulus for a valve,which is releasably carried by a deployment catheter having at least oneinflation lumen extending therethrough. Following positioning of thevalve in the pulmonary vein, the annulus is inflated to the desired sizeand/or pressure, and thereafter decoupled from the deployment catheter.A one way valve 102 on the inflatable support structure 90 preventsescape of the inflation media and/or allows inflation of the inflatablesupport structure 90. The one way valve 102 can be a ball valve, asillustrated in FIG. 11, or another type of valve such as a duck billvalve, pinch or flap valve. The flow control valve 102 illustrated inFIG. 11 has a spring 103 actuated check ball 104 that seals off theinflation lumen 105. A push wire 106 in the delivery catheter 107 can beused to displace the check ball 104 from the default sealing position,thereby unsealing the inflation lumen 105 and permitting the inflatablesupport structure 90 to be inflated. Release tangs 108 can be used tosecure and align the delivery catheter 107 with the flow control valve102.

As illustrated in FIGS. 9G and 9H, in certain embodiments, the firstinflatable chamber 92 is provided such as at the annulus of the valve90, and at least a second inflatable chamber 94 is provided, such as toprovide commissural support and/or to stabilize the valve 90, dependingupon the occluder (i.e. leaflet) configuration as will be appreciated bythose of skill in the art in view of the disclosure herein. In oneembodiment, a first inflatable ring 92 is provided at a proximal end 96of the tubular valve 90, a second inflatable ring 94 is provided at adistal end 98 of the tubular valve 90, and at least one additionalinflatable chamber 100 is provided in between the proximal and distalends 96 and 98, to provide intermediate support. The intermediatesupport chamber 100 may comprise any of a variety of configurations,such as a zig-zag configuration around the circumference of the valvesupport structure. A tissue valve or a synthetic leaflet valve may besecured within the tubular valve support structure 90.

Prosthetic Atrium

As illustrated in FIG. 10, in one embodiment the device 110, such as avalve, is located substantially outside the heart 112. The rightsuperior pulmonary vein 114 a, the right inferior pulmonary vein 114 b,the left superior pulmonary vein 114 c and the left inferior pulmonaryvein 114 d are spliced into and connect together into a prostheticatrium 116. Blood is then directed through a one-way valve 110 andthrough a conduit 118 to the left ventricle 120. The native mitral valvecould be surgically sealed off and/or the native pulmonary veins 114a′-d′ could be sealed, restricted, occluded, or cut, near where theyconnect to the left atrium 122. This procedure could be performed in anopen surgical procedure or in a minimally invasive procedure orpercutaneously, ideally the procedure would be performed on a beatingheart possibly using a thorascope.

In the preferred embodiment where the procedure is performed on abeating heart 122, the prosthesis 116 is first flushed and filled with abiocompatible fluid such as saline to prevent the possibility of an airembolism. Next the outlet conduit 118 is attached to a portion of thenative anatomy, preferably the left ventricle 120, and preferably nearthe apex of the heart 112. The one way valve 110 portion of the implantprevents blood from the left ventricle 120 from escaping uncontrolled.As a next step a pulmonary vein 114 a-d is cut. The atrium 122 side ofthe vein 114 a′-d′ is tied off or otherwise sealed. The section of thepulmonary vein 114 a-d connected to the lungs is attached to one of theinlet conduits 124 a-d of the prosthesis 116. In a similar fashion theremaining pulmonary veins 114 a-d are connected to the prosthesis 116,preferably one at a time.

In one embodiment the prosthetic atrium is supplied as a chamber withsingle outlet conduit 118 and four inlet conduits 124 a-d. A one wayvalve 110 is supplied, attached either to the chamber or in the outletconduit 118, Alternatively the outlet conduit 118 may be designed toallow the insertion and attachment of an available prosthetic valve 110during the procedure. In one embodiment the prosthetic chamber isconstructed from a woven fabric, such as polyester. In anotherembodiment the chamber is constructed from animal tissue such as theaortic root of a pig or the pericardial tissue from a cow. These tissuesmay be fixed using techniques common in the industry, such asglutaraldehyde fixation.

In a similar embodiment the blood is directed from the pulmonary veins,into the prosthetic atrium, past the prosthetic valve and then into thenative atrium.

The prosthetic atrium could be of any volume, from as small as ispractical to larger than a native atrium. The compliance of theprosthetic atrium is also a variable that may be adjusted to achieveoptimal hemodynamics and to limit pulmonary edema.

In another embodiment the pulmonary veins are interrupted and blood ischanneled from the portion of the pulmonary vein nearest the lung,through a prosthetic valve and then back into the portion of thepulmonary vein nearest the atrium. A valve could be placed in one ormore pulmonary vein. Alternatively multiple veins could be joined tochannel blood to a single valve. The flow of blood could then return tothe heart in a single conduit or could be bifurcated into multiplechannels and return to the heart, ideally through the ostium where thenative pulmonary veins met or meet the atrium.

In yet another embodiment the valve is located substantially within thepulmonary veins or the atrium, but the valve is inserted through a slitcut into the pulmonary veins. It is possible that by interrupting flowin less than four of the pulmonary veins and or by a rapid surgicalprocedure, the use of a heart lung machine would not be required tooxygenate the patients blood.

Location

Location between the lungs and left atrium within the pulmonary veinswill allow for single direction flow and protect the lungs from unwantedelevation in pulmonary pressures and fluctuation. The device could beimplanted at any location within the pulmonary vein and may allowadditional compliance if implanted deep into the pulmonary vein. Thismay allow the vein to dilate during higher pressures relieving pressuresseen in the left atrium or pulmonary circulation. Additionally, anaccumulation or expansion chamber may added to the pulmonary vasculatureto allow for pressure variations. This device could be adjusted orcalibrated to the correct or ideal pressures as normally seen in ahealthy human and translate them to the pulmonary circulation. Anotherdevice may be located in the left atrium and consist of a bladdercontaining a fluid such as a gas to relieve excess pressures seen withinthe left atrium.

In one embodiment the device is located in the pulmonary veins near orat the ostium where the veins empty into the left atrium. The valvescould be placed in this location by many methods including surgically orpercutaneously delivery.

In another embodiment the device is located further up the pulmonaryveins closer to the lungs. This location could effectively produce amore compliant and larger volume atrium than the previous embodiment.

In another embodiment the valve is located substantially within theatrium. With this valve location it may be possible to fit a largervalve for improved hemodynamics, or to allow the valve to cover the flowfrom more than one pulmonary vein. This may also aid in anchoring thedevice securely.

Anchoring Methods

The flow control device can be secured in the anatomy by severalmethods. As illustrated in FIG. 6, in one embodiment a portion of thedevice 30 consists of an expandable stent like structure 38 utilizing aninterference fit or surface friction to hold the device 30 in place. Thestent like structure 38 could be made from a malleable alloy such as astainless steel of suitable alloy and condition or cobalt-chromium forbetter visibility under fluoroscopy. The stent like structure 38 wouldthen be expanded mechanically by a balloon or other means, producinginterference fit with the tissue. Alternatively the stent like structure38 could be one of a self-expanding design, manufactured from a superelastic material such as Nitinol, or a material with a large amount ofelastic strain available such as the ellgilloy used in the wall stent.The stent 38 could be manufactured from a tube selectively removingportions with a laser or EDM thus providing optimal expansion andcross-sectional profiles. One skilled in the art of stent design andmanufacture could produce many variations of an embodiment as such.

Another anchoring method is to suture the valve portion to the wall ofthe atrium or to the pulmonary vein. The flow control device may containa sewing ring to allow sutures to be easily attached to the device. Apercutaneous or minimally invasive sewing device may also beincorporated. This device would contain at least one needle remotelyactuated to attach the valve to the tissue, or to a second devicepreviously implanted at the desired valve location. Other methods mayutilize a balloon or other force mechanism to push or pull the sutureinto position.

Another anchoring method is to staple or clip the valve in place withmultiple detachable staples, clips, barbs or hooks. This could beaccomplished surgically with a tool that spaces the clips around theannulus and allows them to engage the tissue and a portion of the valve.The staples, clips, hooks or barbs could also be deliveredpercutaneously with a device that positions the staples, clips, hooks orbarbs relative to the valve. These could be attached through a balloonor other force mechanism to push or pull them into position.

Another anchoring method is to use an adhesive to secure the valve tothe tissue. Adhesives such as a fibrin glue or cyanoacrylate could bedelivered percutaneously or surgically to attach the valve to thetissue.

Size Range

The devices could be made in a variety of diameters to correspond to thevarious anatomy of the patient population. The ideal size of the flowcontrol device designed to be located inside a pulmonary vein may notdirectly correspond to the diameter of the vein. For example in somecases an oversize valve may be preferred because it may offer betterhemodynamics or other advantages. In other cases an undersize valve maybe preferred because it may offer reduced vessel trauma or otheradvantages. The average size of the pulmonary veins is approximately 15mm in diameter. These valves would preferably be manufactured in a rangeof sizes from 3 to 30 mm in diameter, although other sizes may be used.

A flow control device designed for location in the atrium may have arange of sizes significantly larger than the previous embodiment thesevalves may preferably range from 8 to 80 mm in diameter, although othersizes may also be used.

A flow control device designed to be located substantially outside theheart and outside the pulmonary veins may include a valve of a range ofdiameters from 8 to 80 mm.

An orifice type flow control device if located in the pulmonary veinwould require an outside diameter corresponding to the diameter of thevein. The inside diameter would depend on the desired effect on flow,The outside diameter would preferably be approximately 10-20 mm indiameter and may range from 3 to 30 mm in diameter. Other sizes may alsobe used. The internal diameter of the orifice may range from 1 to 20 mmin diameter. An orifice designed to limit flow through the nativearteries when a secondary path for blood flow is provided may be smallerstill. In this case an orifice from, .5 to 5 mm is preferred, althoughother sizes may be used.

Length of device may vary depending upon the style selected. Disk styledevices may range in length from 2-20 millimeters where a ball-cagestyle may range from 2-30 millimeters in length. It is also possible toimplant a plurality or devices into one vessel for additionalperformance. The valve portion of the implant may be located distal,proximal or coaxial to the anchoring portion of the device. Theanchoring potion of the device may range in length from 2-30millimeters.

Congenital Defects

Devices of similar or identical design could be used to treat patientswith congenital defects, For example a patient with a common atrium,where the septal wall between the left and right atrium is missing couldbe treated with a device described above, although the patient does nothave a left atrium the common atrium serves its function and a similardevice could be effective. In another example a patient suffering from atransposition of the great cardiac veins could be treated with a similarvalve.

Procedure Cath-Lab

The procedure is preferably performed in a cardiac catheterization lab,where the normal tools associated with interventional cardiology areavailable. Many of the conventional tools could be used for theimplantation of a valve controlling the flow through the pulmonaryveins. These tools include items such as introducers guide catheters,and guide wires may be used with this device. Some devices specificallydesigned for the valve implantation such as special sizing tools tomeasure diameters and flow characteristics and access tools to engagethe pulmonary veins may be used. A guide catheter with a special curveor curves may be required to access the atrium and pulmonary veins. Thedevice is to be implanted using fluoroscopic guidance or othervisualization means such as CT or MRI. A contrast media such as bariumsulfate may be used to visualize the coronary anatomy. Contrast could beinjected into the pulmonary artery, or one of its branches, to helpvisualize where the pulmonary veins exit the lungs. Contrast could alsobe injected from the tip of the guide catheter when engaged into thepulmonary vein to image the ostium clearly for device placement.

Surgical Suite

Another method of implanting the valve between the pulmonary veins andthe heart is a surgical approach. This procedure is to be performed in asurgical suite. The heart may be exposed by a sternotomy or lateralthoracotomy or through a portal entry or the procedure is performedthrough a puncture or small incision utilizing a minimally invasive tubelike device.

In one version of the procedure the aorta is cross-clamped and the heartis infused with a cardiopelegic solution, A bypass pump is utilized toprovide oxygenated blood to the body especially important organs such asthe brain.

In another version surgical tools are utilized to allow the procedure tobe performed through small incisions in the heart, preventing the needfor the use of the bypass pump, and minimizing the risk of associatedcomplications.

The valves can be placed in any location that allows the control ofblood flow to the atrium from. the pulmonary veins and prevents orminimizes back flow. The valves could be placed in the pulmonary veins.This oilers advantages for percutaneous placement because the systemwould use multiple valves of smaller diameter. The valves could also beplaced inside the atrium this offers the advantage of possiblyimplanting larger valves that could control the flow of blood from oneor more pulmonary vein. The valves could also be positioned in theostium of the pulmonary veins; this provides similar advantages toimplanting the valves in the pulmonary veins but has the advantage thatthe tissue may be easier to secure the device to. The valve or valvescould also be located outside the heart and the blood flow routedthrough the valve or valves in a prosthetic conduit.

Entry Vessel

In the percutaneous procedure access to the pulmonary veins may begained by a puncture into the venous system and a trans-septal puncturefrom the right atrium into the left atrium. In this case access to thevenous system is gained by a puncture into a vein, preferably theinternal jugular vein or the femoral vein would be used, but other veinsare also suitable.

Alternatively in the percutaneous procedure access to the pulmonaryveins may be gained, by a puncture into the arterial system. In thiscase the puncture is preferably performed in the femoral radial orbrachial artery although other arteries may be used as well. Thecatheter is then advanced into the aorta, past the aortic valve, pastthe mitral valve and into the left atrium where it can access thepulmonary veins

Imaging/Monitoring

During the procedure or during patient selection, or follow-up, variousimaging techniques can be used. These include fluoroscopy, chest x-ray,CT scan and MM.

During the procedure or during patient selection, or follow-up, variousflows and pressures may be monitored, or example echocardiography may beused to monitor the flow of blood through the pulmonary veins, and otherchambers and conduits of the coronary system. It may be especiallyimportant to visualize regurgitant flow in the pulmonary veins and pastthe mitral valve. Additionally pressures may be monitored in variouschambers and conduits of the heart; for example pulmonary wedge pressuremay be an important measurement.

On or Off Pump

The surgical procedure may be performed on a cardiac bypass pump. Thiswould allow the device to be implanted with the heart stopped and maynot require a cross-clamp of the pulmonary vein. Alternatively usingsome of the devices and concepts described the surgical procedure may beperformed off pump. While maintaining a beating heart, the operation maybe performed by using a cross-clamp method to isolate a pulmonary vesselusing two clamps to halt the blood flow between the site implantation. Aslit or incision may then be made to insert the valve device into thevessel. Alternatively, a complete separation of the vessel between thetwo clamps and exposing the lumen could be made to implant the valvedevice. Both techniques would require a suture or reattachment of thevessel post implantation and a suture or other means may be required tomaintain proper valve location within the vessel. The techniques ofimplantation of the device would apply to on-pump implants as well.

Second Atrium

In an alternative surgical procedure, preferably performed on a beatingheart. This procedure utilizes a device that consists of a conduitapproximately 20 mm in diameter and a prosthetic valve located in theconduit. The end of the conduit that allows out flow is grafted into theleft ventrical. The one-way valve prevents blood from escaping. Thepulmonary veins are then transplanted from the left atrium to the inletside of the conduit. The small portion of the pulmonary veins remainingon the atrium are closed surgically.

1-8. (canceled)
 9. An implantable prosthetic valve comprising: aninflatable support structure comprising a plurality of inflatableannular rings, wherein a first annular ring of the plurality ofinflatable annular rings is located at a proximal end of the inflatablesupport structure, and wherein a second annular ring of the plurality ofinflatable annular rings is located at a distal end of the inflatablesupport structure; an occluder attached to the inflatable supportstructure, wherein the plurality of inflatable annular rings areconfigured to provide commissural support to the occluder; a tubularcuff around the occluder; at least one inflatable chamber provided inbetween the proximal and distal ends of the inflatable supportstructure, wherein the at least one inflatable chamber forms a zig-zagconfiguration around the circumference of the inflatable supportstructure and is configured to provide intermediate support to theimplantable prosthetic valve; and a one way valve on the inflatablesupport structure, wherein the one way valve is configured for couplingto an inflation lumen for inflating the support structure with aninflation media and for sealing off the inflatable support structureafter decoupling from the inflation lumen.
 10. The prosthetic valve ofclaim 9, wherein the one way valve is a ball valve, a duck bill valve, apinch valve, or a flap valve.
 11. The prosthetic valve of claim 10,wherein the one way valve is a ball valve.
 12. The prosthetic valve ofclaim 10, wherein the ball valve comprises a spring actuated check ball,and the ball valve is configured to be unsealed by displacing the checkball.
 13. The prosthetic valve of claim 9, wherein the occluder is atissue valve, a mechanical valve, a single leaflet valve, or a bileafletvalve.
 14. The prosthetic valve of claim 9, wherein the inflatablesupport structure secures a tissue valve within the inflatable supportstructure.
 15. The prosthetic valve of claim 9, wherein the inflatablesupport structure secures a synthetic leaflet valve within theinflatable support structure.